MULTAQ

Dronedarone is extensively metabolized and has low systemic bioavailability; its bioavailability is increased by meals. Its elimination half-life is 13 to 19 hours.

AbsorptionBecause of presystemic first pass metabolism the absolute bioavailability of dronedarone without food is low, about 4%. It increases to approximately 15% when dronedarone is administered with a high fat meal. After oral administration in fed conditions, peak plasma concentrations of dronedarone and the main circulating act...

14.1 ATHENA ATHENA was a multicenter, multinational, double blind, and randomized placebo-controlled study of dronedarone in 4628 patients with a recent history of AF/AFL who were in sinus rhythm or who were to be converted to sinus rhythm. The objective of the study was to determine whether dronedarone could delay death from any cause or hospitalization for cardiovascular reasons. Initially patients were to be ≥70 years old, or <70 years old with at least one risk factor (including hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or LVEF <0.40). The inclusio...

The following safety concerns are described elsewhere in the label:

• New or worsening heart failure [see Warnings and Precautions (5.4) ]
• Liver Injury [see Warnings and Precautions (5.5) ]
• Pulmonary toxicity [see Warnings and Precautions (5.6) ]
• Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ]
• QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dys...

MULTAQ is contraindicated in patients with:

• Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning , Warnings and Precautions (5.2) ]
• Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning , Warnings and Precautions (5.1) ]
• Second or third-degree atrioventricul...

• Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. ( 5.2 )
• Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. ( 5.3 )
• Liver injury: If hepatic injury is suspected, discontinue MULTAQ. ( 5.5 )
• If pulmonary toxicity is confirmed, discontinue treatment. ( 5.6 )
• Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. ( 5.7 )
• Renal impairment: Monitor renal function ...

7 DRUG INTERACTIONS Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions ( 7 )

• Class I or III antiarrhythmics: Contraindicated. ( 4 , 7.1 )
• Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. ( 7.1 , 7.3 )
• Calcium channel blockers (CCB): Initiate CCB w...